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Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors

Last updated on July 11, 2019

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Study Location
Seoul National University Hospital
Seoul, , 03080 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid
tumors that are not amenable for treatment with curative intent in adult patients
with: NSCLC, TNBC, HR+ breast cancer, recurrent platinum sensitive ovarian cancer, UC,
CRPC, and other advanced solid tumors with a BRCA or ATM gene defect

- Mandatory primary or metastatic tumor biopsy. If archival tumor tissue is available
from a biopsy/surgery the tumor tissue may be submitted without repeating a tumor
biopsy during the screening period.

- Minimum age in Japan is 20 years.

- ECOG performance status 0 or 1.

- Resolved acute effects of prior therapy

- Adequate bone marrow, renal, and liver function.

- Negative serum pregnancy test at screening.

- Pregnant, breastfeeding females or female patients able to have children must agree to
use highly effective method of contraception throughout the study and for at least 30
days after the last dose of avelumab and for at least 7 months after the last dose of
talazoparib; fertile male patients must use a condom during treatment and for at least
4 months after the last dose of talazoparib.

- Signed and dated informed consent.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Prior treatment with a PARP inhibitor.

- Prior immunotherapy with IL-2, IFN-?, or an anti-PD-1, anti-PD-L1, anti-PD-L2,
anti-CD137, OX 40, GITR, LAG 3, IDO, TDO,TIM 3, CTLA-4 antibody, or any other antibody
or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
Prior treatment with Sipuleucel-T for patients with mCRPC is allowed. For cohort A2
NSCLC patients prior treatment with anti-PD-1/L1 is allowed

- Prior anti-cancer therapy within 2 weeks prior to study enrollment. Prior radiation
therapy within 2 weeks prior to enrollment. Prior palliative radiotherapy to
metastatic lesion(s) is permitted, provided it has been completed 2 days prior to
study enrollment and no clinically significant toxicities are expected (eg, mucositis,
esophagitis).

- Major surgery within 4 weeks prior to study enrollment.

- Current use of immunosuppressive medication at the time of study enrollment.

- Known prior or suspected hypersensitivity to investigational products.

- Known history of immune mediated colitis, inflammatory bowel disease, pneumonitis,
pulmonary fibrosis.

- Active or prior autoimmune disease that might deteriorate when receiving an
immunostimulatory agent.

- Prior organ transplantation including allogenic stem-cell transplantation.

- Vaccination within 4 weeks of study enrollment and while on trial is prohibited except
for administration of inactivated vaccines.

- Diagnosis of Myelodysplastic Syndrome.

- Patients with known brain metastases requiring steroids.

- Participation in other studies involving investigational drug(s) within 4 weeks prior
to study participation and/or during study participation.

- Persisting toxicity related to prior therapy >Grade 1

- Known HIV or AIDs-related illness.

- Positive HBV or HCV test indicating acute or chronic infection.

- Active infection requiring systemic therapy.

- Clinically significant cardiovascular disease: cerebral vascular accident/stroke or
myocardial infarction within 6 months prior to study entry; unstable angina,
congestive heart failure or a serious cardiac arrhythmia requiring medication.

- Current or anticipated use within 7 days prior to first dose of study drug, or
anticipated use during the study of a strong P-gp inhibitor.

- Other acute or chronic medical or psychiatric conditions.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Capsules
Intravenous injections
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
A placebo is not used in this trial
Duration
The time commitment for participation in the study.
Follow up: Estimated 12 weeks
Screening: Estimated 4 weeks
Treatment: Estimated 36 weeks
Site Visits
Follow up: Range 0 visits
Screening: Range 1 visits
Treatment: Range 1 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Keeping a diary
Mri
Cat scan
Physical examination
Electrocardiogram (ECG)
Biopsy
Urine test
Other
Blood test
Vital signs and measurements
NCT03330405
Pfizer
Recruiting
Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors

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